Dansac
Ref 072-64
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number5709817D02P013S014937 05709817607888 | Date3 Oct 2025 | StatusActive |
Certificates
No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Ostomy Seals
- Model / Reference
- 072-64
- Primary DI / UDI-DI
- 05709817607888
- Basic UDI-DI
- 5709817D02P013S014937
- Unit of Use DI
- 25709817607882
- EMDN Code
- A108001 Rings / bezels / plates for peristomal skin
- Device Class
- Class I
- EU market of registration
- Denmark
Manufacturer details
- EUDAMED SRN
- DK-MF-000001514
Other devices from Dansac A/S
Properties
Other properties (13)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No